VALIANT® Captivia VAMF4242C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169347342), received between Feb 28, 2017 and Feb 16, 2023 — classified as 1 death, 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 5.2 CM SACCULAR ANEURYSM .  IT WAS REPORTED THAT ON THE DATE OF A ROUTINE CT , A TYPE A DISSECTION WAS OBSERVED.  PER THE PHYSICIAN THE CAUSE OF THE TYPE A DISSECTION IS UNKNOWN.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 16384848 ↗
• DeathFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK ON AN UNKNOWN STENT GRAFT.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY 2 DAYS POST THE INDEX PROCEDURE WITH SEVERE CHEST PAIN. A CT PERFORMED SHOWED A RETROGRADE TYPE A DISSECTION. THE PHYSICIAN SAID THAT THEY DID BALLOON IN THE ARCH WHERE STENTS OVERLAPPED, WHICH COULD BE A CAUSE.  IT WAS QUERIED IF THE RADIAL FORCE OF THE BARE METAL PROXIMAL SPRINGS COULD HAVE CAUSED THE RTAD. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 13439820 ↗
• InjuryFeb 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A FOLLOW UP CT REVEALED A PROXIMAL TYPE I ENDOLEAK PRESENT DUE TO MIGRATION OF THE VALIANT STENT GRAFT. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER VALIANT STENT GRAFT AND PERFORMED A CAROTID TO LEFT SUBCLAVIAN BYPASS. PLACEMENT OF THE VALIANT PROXIMAL EXTENSION PIECE WAS DONE IN A STANDARD MANNER. WHILE ATTEMPTING TO EMBOLIZE THE LSA ORIGIN WITH ANOTHER MANUFACTURER¿S PLUG, THE PLUG WAS DEPLOYED, THE SHEATH WAS WITHDRAWN, A CONTRAST INJECTION DEMONSTRATED POSSIBLE EXTRAVASATION. ANOTHER MANUFACTURER¿S COVERED STENT WAS DEPLOYED IN AN ATTEMPT TO COVER A SUSPECTED VASCULAR PERFORATION, AN ANGIOGRAM DEMONSTRATED POSSIBLE EXTRAVASATION, THEREFORE ANOTHER MANUFACTURER¿S PLUG AND EMBOLIZATION COILS WERE DEPLOYED INSIDE THE COVERED STENT. NO FURTHER EXTRAVASATION WAS OBSERVED. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN. A CT DEMONSTRATED A SUSPECTED RETROGRADE TYPE A DISSECTION ON THE LESSER CURVE AT THE LOCATION OF THE PROXIMAL STENT GRAFT. THE PHYSICIAN ELECTED TO PERFORM A HEMI-ARCH REPLACEMENT WITH A SURGICAL GRAFT

  Patient problems: Pain; Vascular Dissection

  MAUDE report 6366280 ↗